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Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac arrest. Hypothermia seems promising also in other acute hypoxic-ischemic or in brain swelling associated cerebrovascular disease. The narrow-time-frame is a major issue ("time is brain"). To provide immediate cooling without delay, easy to use, mobile and effective methods are needed. Cold infusions (4 °C) are an accepted standard worldwide. EMCOOLS Flex.Pads (Emergency Medical Cooling Systems AG, Wien, Austria) is a new non-invasive surface cooling system. A comparison of these two induction methods has never been done before. Neither was the effect of EMCOOLS Flex.Pads on brain-temperature measured. For the first time iCOOL 2 compares feasibility, safety and efficacy of the two methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cold infusions | Active Comparator | Infusion of 2L cold crystalloid solution (4°C) over 30 minutes |
|
| EMCOOLS Flex.Pads | Active Comparator | Passive surface cooling with 10 EMCOOLS Flex.Pads (Emergency Medical Cooling Systems AG, Wien, Austria) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold crystalloid infusions, 0.9%NaCl or Ringer's solution | Drug | Infusion of 2L cold crystalloid solution (4°C) over 30 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brain temperature | Primary endpoint: Change of brain temperature during one hour after start of cooling. Repeated measurement ANOVA for within subject contrasts (phase 1 (0 to 15min), 2 (15 to 30min), 3 (30 to 45min) and 4 (45 to 60min)) vs. baseline (-15 to 0min) | -15 to +60min |
| Measure | Description | Time Frame |
|---|---|---|
| (Neuro-)vital parameters | Effects on (neuro-)vital parameters (e.g. HR, AP, ICP, CPP) are registered | -15 to +180 min |
| Cerebral autoregulation | Cerebral auto-regulation parameters (e.g. PRx) are calculated on the basis of the (neuro-)vital parameters monitored. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sven Poli, Dr. med. | Contact | 0049 6221 56 | 0 | sven.poli@med.uni-heidelberg.de |
| Name | Affiliation | Role |
|---|---|---|
| Sven Poli, Dr. med. | University Hospital Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuro Intensive Care Unit 2, Dept. of Neurology, University Hospital Heidelberg | Recruiting | Heidelberg | 69120 | Germany |
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| EMCOOLS Flex.Pads | Device | Passive whole-body surface cooling with 10 EMCOOLS Flex.Pads |
|
|
| 15 to +180 min |
| Safety | Various safety parameters, such as bleeding complications, cardiac decompensation, or local skin irritations are assessed. | 0 - 7 days |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D000083302 | Hemorrhagic Stroke |
| D007035 | Hypothermia |
| D020521 | Stroke |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000077331 | Ringer's Solution |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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